Implanting cardiac devices

ABSTRACT

A method of implanting a cardiac device featuring the insertion of an inner seal member through an opening in a pericardium about a living human heart. The inner seal member has a first sealing lip disposed inside the pericardium and surrounding an aperture through the inner seal member. An outer seal member is aligned with the inner seal member. The outer seal member has a second sealing lip disposed outside the pericardium, surrounding an aperture through the outer seal member. The inner seal member is secured to the outer seal member. The firsts sealing lip is engaged against an inner surface of the pericardium. The second sealing lip is engaged against an outer surface of the pericardium. A cardiac device is inserted into the pericardium through the apertures of the inner and outer seal members.

PRIORITY CLAIMS

The present application claims priority to German patent applicationserial no. DE 102013200150.9, filed Jan. 8, 2013, and DE 102013200153.3,filed Jan. 8, 2013, the entire contents of each of which is incorporatedherein by reference and relied upon.

TECHNICAL FIELD

The invention pertains to a device to support cardiac function. Inparticular, the device according to the invention serves to support apumping function of a heart.

BACKGROUND

Due to illness, the pumping function of a heart can be reduced, which isalso called cardiac insufficiency. Cardiac insufficiency is from themedical as well as from the economical standpoint of great andincreasing importance. In the second decade of this century, 23 millionpeople worldwide will suffer from cardiac insufficiency; the annual rateof new cases will be about 2 million people. In the US alone, 5 millionpeople are currently suffering from cardiac insufficiency. Here, theannual rate of new cases is approximately 550,000 people. Already inthis decade, the number of incidences in people over 50 years of agewill double to more than 10 million. The same applies to the Europeancontinent.

Causes for cardiac insufficiency can be impaired contractility orreduced filling of the cardiac chambers due to damage to the myocardium.Hypertension can lead to an increased pumping resistance, which can alsonegatively affect the pumping function of the heart. The pumpingfunction of a heart can also be reduced by leaking valves (e.g., aleaking aortic valve or mitral valve). Impairments of the cardiacconduction system generate arrhythmias, which can also lead to a reducedpumping function of the heart. If the movement of the heart isrestricted from the outside, e.g., due to an accumulation of fluid inthe pericardium, this can result in a reduced pumping function as well.Cardiac insufficiency often leads to shortness of breath (especially inthe case of left ventricular insufficiency), or to water retention inthe lungs or in the abdomen (in particular in the case of rightventricular insufficiency).

Different types of cardiac insufficiencies are treatable with medicationor surgery. In some cases of arrhythmias, normal cardiac rhythm can berestored with a pacemaker. A leaking valve can be replaced surgicallywith a cardiac valvular prosthesis. A reduced pumping function can beassisted by an implanted heart pump. A treatment approach addressing thevarious causes of heart insufficiency is to assist the pumping functionof the heart by means of an implant, which exerts mechanical pressureonto the heart and therefore improves its pumping performance.

Some known mechanical ventricular assist devices have been disclosed inU.S. Pat. No. 5,749,839 B1 and U.S. Pat. No. 6,626,821 B1, and in WOapplication 00/25842. These documents disclose mechanical ventricularassist devices that require open-chest surgery. Many cardiac assistsystems are complex and can only be implanted by means of an elaboratesurgical procedure. All cardiac assist systems are integrated into theblood circulation of the patients. Improved centrifugal or magneticallysupported impeller systems carry blood continuously. The contact of theblood with the surface of the implanted systems poses a greatengineering and medical challenge. Common complications of cardiacassist systems are strokes, hemorrhage and septicemia. They often leadto long-term hospitalization and frequent re-admissions of patientsalready released from the hospital.

SUMMARY

Various aspects of the invention feature methods of implanting a cardiacdevice, and systems for performing such a method. According to oneaspect of the invention, the method includes inserting an inner sealmember through an opening in a pericardium about a living human heart.The inner seal member has a first sealing lip disposed inside thepericardium and surrounding an aperture through the inner seal member.An outer seal member is aligned with the inner seal member. The outerseal member has a second sealing lip disposed outside the pericardiumand surrounding an aperture through the outer seal member. The innerseal member is secured to the outer seal member, with the firsts sealinglip engaged against an inner surface of the pericardium and the secondsealing lip engaged against an outer surface of the pericardium. Acardiac device is inserted into the pericardium through the apertures ofthe inner and outer seal members.

In various aspects of the invention a device for the support of thecardiac function includes a sheath configured to transition from anon-expanded state into an expanded state, with the sheath beingself-expanding and being configured to be inserted into a deliverysystem, and which in the expanded state can at least partially enclose aheart. One potential advantage of the device is that it may be implantedusing minimally invasive procedures.

In some implementations, the sheath can be made of a wire mesh, whichcan have diamond-shaped cells. Preferably, the mesh is made of a shapememory alloy. The crossing points of the wires of the wire mesh can bepermanently attached to each other, thus increasing the stability of thesheath. The crossing points may also be separable, which increases theflexibility of the sheath and thereby can make the sheath easier tocompress. Or some of the crossing points may be permanentlyinterconnected while other crossing points are not permanentlyinterconnected. By selecting suitable crossing points to be permanentlyinterconnected, and crossing points that are not permanentlyinterconnected, the stability and flexibility of the sheath can beadjusted.

According to one aspect of the invention, the sheath can also consist ofa lattice structure, with the lattice structure consisting of links, andmultiple links defining one cell. The lattice structure exhibits adiamond-shaped lattice structure. The links and the intersections of thelinks exhibit enforcements in order to increase the stability of thesheath. The effect of the enforcements is similar to the effect of theinterconnected crossing points in embodiments of the sheath in the formof a wire mesh. The links and the intersections can also be made of athinner or weaker material in order to increase the flexibility of thesheath. The effect of a thinner or weaker material at intersections issimilar to the effect of the non-interconnected intersections inembodiments of the sheath in the form of a wire mesh.

The sheath can also be made of a solid material, from which parts havebeen removed. For example, the sheath can be made of a tube or anindividually shaped sheath sleeve, into which holes have been formed orcut. The holes can be formed such that the sheath exhibits increasedstability in some areas, and increased flexibility in other areas.

Generally, areas of increased stability are desired in situations, inwhich the sheath acts as an abutment. Areas of greater flexibility canenable the natural motion of the heart. Increased flexibility is alsoadvantageous for compressing the sheath into a delivery system.

The sheath generally exhibits openings being created by the wires of thewire mesh, the links of the lattice structure, or by the holes formed inthe sheath sleeve. The openings can be rectangular, diamond-shaped orround. The cells or holes can have a pin opening of 1 mm to 50 mm. A pinopening is defined as the largest diameter of a pin, which can be pushedthrough a cell or a hole. Using the holes, the stability and flexibilityof the sheath can be adjusted individually. The holes also allow theexchange of substances from the inside of the sheath with the outerenvironment of the sheath.

The sheath can be covered with a membrane; the membrane may, inparticular, be made of polyurethane, silicon or polytetrafluorethylene(PTFE). The membrane can reduce the mechanical stress exerted by thesheath onto the pericardium or the myocardium. The membrane can alsoincrease the biocompatibility of the sheath. A coating of the membranewith an active substance is also conceivable.

Another aspect of the present invention features a method ofmanufacturing a cardiac assist device. The method includes using avirtual or real image of a heart and forming a sheath based on the shapeof the heart image.

The method can be used to manufacture a custom-made sheath. The shape ofthe sheath can match the form of the 3D-image of the surface of theheart, spatially stretched by a factor. In particular, the stretchfactor can range from 1.01 to 1.2. A sheath applied to a true-to-scalereal or virtual 3D image of the heart should exhibit a distance to the3D image of 1 to 10 mm, in particular 2 to 8 mm, in particular 3 to 5mm.

Additional features and advantages of the invention will be apparentfrom the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a human torso with an implanted device and anextracorporeal supply unit.

FIG. 2 shows a human torso with an implanted device and a partiallyimplanted supply unit.

FIG. 3 shows a human heart with the device.

FIGS. 4 a and 4 b show a cross-section through the heart with the devicealong line A-A in FIG. 3.

FIG. 5 shows a step of the implantation of the device.

FIG. 6 shows a step of the implantation, in which a pericardium seal hasnot yet been screwed shut.

FIG. 7 shows a step of the implantation, in which a pericardium seal isscrewed shut.

FIG. 8 shows a partially expanded sheath with a sleeve.

FIGS. 9 a-c show different views of a closed pericardium seal.

FIG. 10 shows a tool for the closing of a pericardium seal.

FIG. 11 shows a plug connector system of the device.

FIG. 12 a shows a heart with anatomical points of reference.

FIG. 12 b shows a cross-section of the heart from FIG. 12 a.

FIG. 13 a shows a 3D view of part of a heart with a system ofcoordinates.

FIG. 13 b shows a 2D-rollout of the 3D view from FIG. 13 a with a systemof coordinates.

FIG. 14 a shows a 3D view of a sleeve with augmentation and positioningunits.

FIG. 14 b shows a 2D rollout of a sleeve with augmentation andpositioning units from FIG. 14 a.

FIGS. 15 a-b show one compressed and one expanded augmentation unit inthe form of a chamber with a bellows-type section.

FIG. 16 a shows a 3D view of a sleeve with sensors and/or electrodes.

FIG. 16 b shows a 2D rollout of the sleeve with sensors and/orelectrodes from FIG. 16 a.

FIG. 17 shows a sample embodiment for a sleeve with augmentation andpositioning units.

FIG. 18 shows a sample embodiment for a sleeve with sensors andelectrodes.

DETAILED DESCRIPTION

FIG. 1 shows an embodiment (10) of a device in the implanted state. Inthis example, the device is implanted into a human body. The device,however, can also be implanted into an animal body, in particular intothe body of a mammal like a dog, a cat, a rodent, a primate, aneven-toed ungulates or an odd-toed ungulate. Depending on the species,the form and the mode of operation of the device is adjusted, in orderto accommodate anatomical and/or physiological needs of the individualspecies.

FIG. 1 shows a human torso with the device. The device includes a sheath(2), which can at least partially enclose the heart (61). Multiplecomponents inserted in the sheath (2) support the cardiac function (61).The device also includes a supply unit (30).

The sheath (2), which can at least partially enclose the heart (61), isconfigured to transition from a non-expanded state into an expandedstate. Preferably, the sheath (2) is self-expanding and can be insertedinto a delivery system in the non-expanded state. The sheath (2) can bea mesh, in particular a wire mesh, whereby the wire mesh can be at leastpartially made of a shape memory alloy.

The sheath (2) at least partially encloses the heart (61) in theimplanted state and is located inside the pericardium (6). Embodimentsin which the sheath (2) is placed outside of the pericardium (6) arepossible as well. These embodiments are not described separately;rather, the description for embodiments for implantation inside andoutside the pericardium (6) (with the exception of the not-requiredpericardial seal (5) in embodiments of the sheath (2) for implantationoutside the pericardium (6)) is applicable. The architecture of thesheath (2) is explained in greater detail in a later section of thedescription.

Located inside the expandable sheath (2) is at least one expandableunit, which can be used to apply pressure to the heart (61). Theexpandable unit can be a mechanical unit, configured to transitionbetween an expanded and a non-expanded state. Such a mechanical unit caninclude spring elements, which can be tensioned and released, or leverelements, which can be folded and unfolded. Preferably, the expandableunits are chambers, which can be filled with a fluid. Suitable fluidsfor the filling of a chamber include liquids, gases, or solids (likenanoparticle mixtures, for example), or mixtures of fluids and/or gasesand/or solids. The expandable unit can be secured inside the sheath (2).Preferably, the expandable unit is attached to a sleeve, which can beinserted into the sheath (2). The at least one expandable unit isdescribed in greater detail with reference to FIG. 8.

The sheath (2) can furthermore include at least one sensor and/or oneelectrode, which can be used to detect at least one parameter of theheart (61). The sensor can be configured to determine the heart rate,the ventricular pressure, the contact force between the heart wall andthe expandable unit, the systolic blood pressure, the diastolic bloodpressure, the pressure applied to a surface of the heart, the fluidpresence, the acidity, the electrical resistance, the osmolarity, theoxygen saturation or the flow through a vessel. The sensor can also beconfigured to measure the pressure applied by an expandable unit onto asurface, the pH-value, the electrical resistance, the osmolarity of asolution, the oxygen saturation of tissue or blood or the flow through avessel. The sensor can be attached inside or on the sheath (2).Preferably, the sensor is secured on a sleeve configured to be insertedinto the sheath (2). In addition to the at least one sensor or in placeof the sensor, the sheath (2) can also include at least one electrodeconfigured to measure a parameter, like e.g. the action potential at themyocardium during the excitation process, or to stimulate a tissue withcurrents. The sensor can also be an electrode. The sensor and theelectrode are explained in greater detail in a later section of thedescription.

FIG. 1 shows a supply unit (30), which can be worn outside the body. Thesupply unit can also be partially or completely implanted into the body,which will be explained in the following sections in greater detail. Ifthe supply unit (30) is worn outside the body, it may be attached to achest belt, to a hip belt, or to an abdominal belt. The supply unit (30)is equipped with an energy storage device allowing the expandable unitto be powered. The energy storage device can be available in the form ofa rechargeable battery providing electrical energy to expand theexpandable unit. The rechargeable battery is exchangeable. The supplyunit (30) can also include a pressure storage device supplying acompressed gas, to inflate an inflatable chamber. Suitable gases are,among others, compressed air, CO₂, or inert gases. The housing of thesupply unit (30) itself can serve as a pressure storage housing. Thesupply unit (30) can furthermore contain pumps, valves, sensors anddisplays. The supply unit (30) can furthermore include a microprocessorconfigured to receive and process data from the at least one sensor. Ifthe supply unit (30) is worn outside the body, the required energy canbe transferred by direct connection via a cable (4) or connectionlessvia electromagnetic induction, for example. The data from the at leastone sensor can also be transmitted directly via a cable (4) orconnectionless via wireless technology like bluetooth, for example.

The device can furthermore include a cable (4) connecting the expandableunit and/or the sensor or the electrode to the supply unit (30). If thesupply unit (30) is connected directly to the expandable unit and/or tothe sensor, or the electrode, a cable (4) is not required. If theexpandable unit is a mechanical unit which, using electrical energy, isconfigured to transition from a non-expanded state into an expandedstate, or from an expanded state into a non-expanded state, the cable(4) includes lines configured to transfer the required energy from thesupply unit (30) to the expandable unit. The sleeve can include internalchambers, configured to enable hydraulic alteration of the volume of atleast one of the internal chambers of the sleeve. If the expandable unitis a chamber that can be filled by means of a fluid, the cable (4)includes at least one line allowing the flow of fluid from the supplyunit (30) into the chamber. In some implementations, the cable (4)includes at least one pneumatic or hydraulic line. If the deviceincludes one sensor or one electrode at, in or on the sheath, then theline leading to the sensor or the electrode can also be in the cable(4). Embodiments can also exhibit separate cables for providing energyfor the expandable unit and for the sensor, or the electrode.

The cable (4) connecting the supply unit (30) to the expandable unitand/or the sensor, or the electrode, can be a single continuous cable ora multi-part cable. In the case of a continuous cable connection, thecable (4) can be attached to the expandable unit and/or the sensor orone electrode. A connector (90) can be attached to the end of the cable(4). The connector (90) can be connected to the supply unit (30) via thematching connector (91). Alternatively, a cable with a connector is onlyattached to the supply unit (30). In this case, the matching connectoris installed on the sheath (2), on the expandable unit and/or on thesensor or electrode. In case of a multi-part cable, a cable (4) with aconnector (91) can be attached to the expandable unit and/or at thesensor or the electrode, and a cable can also be attached to the supplyunit (30), at the end of which can be a connector. The cable (4) and theconnector (90) are described in greater detail in a later section of thedescription.

FIG. 2 shows an embodiment (11) of the device in the implanted state,where the supply unit (31) is implanted into the body. Preferredlocations for the implantation of the supply unit (31) are the chest(thoracic) cavity and the abdominal (peritoneal) cavity, which areseparated from each other by the diaphragm (63).

The sheath (2) shown in FIG. 2, the pericardium seal (5), and the cable(4) of the device are essentially identical to the components shown inFIG. 1. The supply unit (31) can include an energy storage device, whichcan be used to power the expandable unit located inside the sheath (2).The energy storage device can be provided in the form of a rechargeablebattery, which supplies electrical energy in order to expand theexpandable unit. The supply unit (31) can furthermore contain sensorsand one or more microprocessors. If the expandable unit includes atleast one chamber, which can be filled with a fluid, then the supplyunit (31) can include pumps, valves, and a pressure reservoir. Thepressure reservoir can provide a compressed gas in order to inflate aninflatable chamber. Suitable gases are, among others, compressed air,CO2, or inert gases. The housing of the supply unit (31) itself canrepresent the housing of the pressure reservoir. A preferred place forthe implantation of the supply unit (31) is inside the right lateralchest cavity above the liver (62) and above the diaphragm (63).Alternatively, or in addition to the pressure reservoir (32) in thesupply unit (31), the pressure reservoir (32) can be preferablyimplanted inside the right lateral abdominal cavity below the diaphragm(63) and above the liver (62).

The pressure reservoir (32) can be connected to the supply unit (31)with a tube (33), which penetrates the diaphragm (63). The opening inthe diaphragm required for the tube (33) to pass through can be sealedwith a seal. The seal can be designed similar to the pericardium seal,as previously described. The supply unit can be connected via a cable(4) directly with the expandable unit and/or the sensor, or theelectrode. Alternatively, at the end of the cable (4) can also be aconnector configured to connect via a matching connector to the supplyunit (31) or to the expandable unit and/or to the sensor or theelectrode.

The cable (4) runs preferably in the chest cavity above the diaphragm(63). In the case of a multi-part cable, a cable with a connector can beattached to the expandable unit and/or the sensor or one electrode, anda cable with a matching connector can be attached to the supply unit(31).

Alternatively or in addition to a rechargeable battery in the supplyunit (31), a rechargeable battery (34) can be implanted subcutaneously,into the abdominal wall. The energy required in the supply unit (31) canbe transferred, for example, by electromagnetic induction from anextracorporeal controller (35) transcutaneously to the rechargeablebattery (34) and be transmitted by an electric cable (36) from therechargeable battery (34) to the supply unit (31). The extra-corporealcontroller (35) can include an exchangeable rechargeable battery and/ora charging device. The extracorporeal controller (34) can contain, amongothers, microprocessors and displays, which can be used for systemmonitoring of the device and for a display of the operating status. Thedata from the sensor can be transmitted connectionless via a wirelesstechnology like bluetooth, for example, to and between the supply unit(31) and the controller (34).

FIG. 3 shows an example of a human heart (61), as well as a sheath (2),a sleeve (7) with expandable units (71, 72), a sleeve (80) with sensors(81) and/or electrodes a cable (4) with a connector (90), a catheter(103) of a delivery system, and a pericardium seal (5) of the device.

In this embodiment, the sheath (2) is shown in the form of a wire mesh.Instead of a wire mesh, the sheath (2) can alternatively be formed as alattice consisting of links. In this case, the links create a latticestructure with openings. The sheath (2) can also consist of a continuousmaterial, from which parts have been removed; for example, the sheath(2) can consist of a tube and an individually shaped sheath sleeve, intowhich holes have been formed or cut.

The sheath (2) represented in FIG. 3 consists of a mesh made of wires.The wires form crossing points (intersections), which can be permanentlyinterconnected. The wires could, for example, be welded together attheir crossing points. Connecting the wires at crossing points increasesthe stability of the sheath (2). The crossing points can be free fromeach other, increasing the flexibility of the sheath (2) and thereforeleading to an easier compressibility of the sheath (2). In someembodiments, the sheath includes wires that do not cross each other,forming longitudinally oriented struts. Increased sheath flexibility isespecially helpful if the sheath (2) is to be inserted into a deliverysystem with a smaller diameter catheter (103). Some of the crossingpoints of the sheath (2) can also be permanently interconnected andothers not. Through appropriate selection of crossing points that arepermanently interconnected and crossing points that are separable, thestability and flexibility of the sheath (2) can be customized. Areasrequiring increased stability in the implanted state can be stabilizedby connecting the wires at the crossing points. These can be areasserving as bearing surfaces or abutments for expandable units (71, 72).Such abutments can be located directly under an expandable unit (71, 72)or next to areas with expandable units (71, 72). Areas requiringincreased flexibility can be areas which during insertion into adelivery system must be compressed more than other areas. Areasrequiring increased flexibility can also be areas, in which an increasedflexibility supports the natural movement of the heart. If the sheath(2) is not made of a wire mesh but of a latticework or a sheath sleevewith holes, the stability and/or the flexibility of selected areas ofthe sheath (2) can be adjusted as well. In these cases, adjustments canbe brought about by choosing the width of the links and/or the thicknessof the links, through the choice of the material to be used, throughmodifications of the material in certain areas through application ofenergetic radiation, like heat, for example. Preferably, the sheath (2)exhibits openings being formed by the wires of a wire mesh, the links ofa latticework, or the holes in a sheath sleeve. These openings enablecompression of the sheath (2); they allow the exchange of substancesfrom inside the sheath (2) with areas outside the sheath (2) and viceversa; they reduce the amount of material being used for the sheath (2),and they allow an increased flexibility of the sheath (2). Shapes whichare difficult to realize with solid materials are easier to achieve withmesh-type or lattice-type structures. The openings can be rectangular,round or oval. The openings defined by the wires, the links or the holesin a sheath sleeve have a diameter of approximately 1 to 50 mm,preferably 4 mm to 10 mm. The diameter of an opening is defined as pinopening, meaning that the diameter of the opening represents the largestdiameter of a cylindrical pin that can pass through an opening (e.g., acell or a hole).

The sheath (2) is preferably made of a material allowing expansion.Preferably, the sheath (2) is formed from a material selected from thegroup consisting of nitinol, titanium and titanium alloys, tantalum andtantalum alloys, stainless steel, polyamide (PA), polyurethane (PUR),polyether ether ketone (PEEK), polyethylene (PE), polypropylene (PP),polycarbonate (PC), polyethylene terephthalate (PET), polymer fibermaterials, carbon fiber materials, aramide fiber materials, glass fibermaterials and combinations thereof. A material suitable for forming aself-expanding sheath (2) is at least partially made of a shape memoryalloy. Examples of shape memory alloys include NiTi (nickel-titanium;nitinol), NiTiCu (nickel-titanium-copper), CuZn (copper-zinc), CuZnAl(copper-zinc-aluminum), CuAlNi (copper-aluminum-nickel), FeNiAl(iron-nickel-aluminum) and FeMnSi (iron-manganese-silicon).

The sheath (2) preferably exhibits a form adapted to the individualshape of the patient's heart, or a cup-shaped form. The individual shapeof the patient's heart can be reconstructed from CT or MRI image data.The sheath (2) is open at the top. The upper rim of the sheath (2)preferably exhibits loops of a wire or straps, which are formed bylinks. The loops or straps can serve as anchoring points for a sleeve(80) with at least one sensor (81) or one electrode, and/or for a sleeve(7) with at least one expandable unit (71, 72). Positioned at the lowerend of the cup-shaped sheath is preferably an opening, through which oneor multiple leads of the sensor (81) or of the electrode, and/or of theexpandable unit (71, 72) can be passed. The shape of the sheath (2) atleast partially represents the anatomical shape of a heart (61), inparticular the lower part of a heart (61). Details regarding the shapeof the sheath (2) are explained in greater detail in a later section ofthe description.

The sheath (2) can be covered by a membrane (21), in particular by amembrane (21) made of polyurethane or silicon. The membrane (21) isconfigured to reduce the mechanical stress applied by the sheath (2)onto the pericardium (6) or the myocardium (61). The membrane (21) canalso increase the biocompatibility of the sheath (2). The membrane (21)can be attached to the inner surface or to the outer surface of thesheath (2). The membrane (21) can also be manufactured by dipping themesh- or lattice-type sheath (2) into an elastomer-containing liquid,which subsequently envelops the latticework or the mesh. The membrane(21) can then stretch across the openings of the mesh or the lattice. Amembrane (21) on the mesh or the lattice can also improve the abutmentproperties of an expandable unit (71, 72). If an expandable unit (71,72) is, for example, an inflatable chamber, then a membrane (21) across,at or on the mesh or the lattice can prevent parts of the chambers beingpressed through the mesh or the lattice while the chamber is expanding.The membrane (21) can furthermore prevent excessive widening of thesheath (2), in particular during inflation of an inflatable chamber. Amembrane (21) on a mesh or a lattice can ensure that an expandable unitpositioned on the lattice or the mesh expands into a direction from themesh or lattice towards the inside only. The membrane (21) does notinterfere with the compressibility of the sheath (2) while beinginserted into a delivery system.

The sheath (2) and/or the membrane (21) can also include an activepharmaceutical ingredient, for example, an anti-thrombotic ingredient,an anti-proliferative ingredient, an anti-inflammatory ingredient, ananti-neoplastic ingredient, an anti-mitotic ingredient, ananti-microbial ingredient, a biofilm synthesis inhibitor, an antibioticsingredient, an antibody, an anti-coagulating ingredient, acholesterol-lowering ingredient, a beta blocker, or a combinationthereof. Preferably, the ingredient is in the form of a coating on thesheath (2) and/or the membrane (21). The sheath (2) and/or the membrane(21) can also be coated with extra-cellular matrix proteins, inparticular fibronectin or collagen. Bio-compatible coating can beadvantageous if ingrowth of the sheath (2) is desired.

The expandable unit (71, 72) is located inside the sheath (2). FIG. 3shows a sheath (2), into which a sleeve (7) with expandable units (71,72) in the form of inflatable chambers is inserted. The expandable unit(71, 72) is being supplied by a line (41) inside the cable (4). Theexpandable unit (71, 72) can be a hydraulic or a pneumatic chamber. Theexpandable unit (71, 72) can be attached directly to the sheath (2)without a sleeve (7). The expandable unit (71, 72) can also be attachedto a sleeve (7), and the sleeve (7) can be attached inside the sheath(2). The expandable unit (71, 72) can be designed to apply pressure tothe heart (61). The applied pressure can be a permanent pressure, or itcan be a periodically recurring pressure. The device can includedifferent types of expandable units (71, 72). The device can include atleast one augmentation unit (71). The device can include at least onepositioning unit (72). The augmentation unit (71) and/or the positioningunit (72) can be attached directly to the sheath (2) or onto a sleeve(7), which is inserted into the sheath (2).

An augmentation unit (71) is a unit that can be periodically expandedand relaxed, and thereby applies a rhythmical pressure to the heart(61). The pressure is preferably applied in the areas of the heartmuscle, under which a ventricle is located. By applying pressure on aventricle by means of the augmentation unit (71) the natural pumpingmotion of the heart (61) is being amplified or substituted, and theblood inside the heart (61) is pumped from the ventricle into thedischarging artery. A pressure applied by an augmentation unit (71) to aright ventricle assists the ejection of the blood from the rightventricular chamber into the pulmonary artery. A pressure applied by anaugmentation unit (71) to a left ventricle assists the ejection of theblood from the left ventricular chamber into the aorta. The positioningof the augmentation unit (71) inside the sheath (2) is explained ingreater detail in a later section of the description.

A positioning unit is preferably expanded during the operation of thedevice in support of the heart function more statically thanperiodically. The positioning unit (72) can be expanded in order to fixthe device to the heart and to ensure proper fitting of the device. Apositioning device (72) can also be used to respond to changes in themyocardium (e.g., shrinking of the myocardium due to lack of fluids orenlargement of the myocardium due to the absorption of fluids). If thesize of the myocardium decreases or increases within a particular periodof time, a positioning unit can be expanded or relaxed further in orderto ensure a perfect fit. The positioning unit (72) may, for example,also be used to ensure that the device does not lose contact to theheart wall over the span of a heartbeat. Loss of contact can lead toimpact stress between the myocardium and the device, and/or causemalfunction of the sensors (81) and/or electrodes. In someimplementations, the positioning unit (72) can counteract thepathological, progressive expansion of the damaged myocardium in heartfailure patients. The positioning of the positioning unit (72) insidethe sheath (2) is explained in greater detail in a later section of thedescription.

Located at the lower end of the sheath (2) can be an opening, throughwhich the lead (83) from the sensor (81) or the electrode and/or theline (41) of the expandable unit (71, 72) can be passed. The opening canbe installed at the lower distal end of the sheath (2). Alternatively,the opening can also be installed on one side of the sheath (2). Shownin FIG. 3 is an opening at the lower distal end of the sheath (2),through which one cable (4), which includes all leads (41, 83), has beenrouted. Instead of one cable (4), there can be multiple separate cables.The cables can be routed through one opening of the sheath (2) orthrough multiple openings of the sheath (2). Attached to the end of thecable (4) is a connector (90), which is used to connect the sensor (81)or the electrode, and/or the expandable unit (71, 72) to a supply unit.The sheath (2) is preferably brought inside the pericardium (6). Thecable (4) is then passed through the pericardium (6). The device caninclude a pericardium seal (5). The seal can seal the opening of thepericardium, which is required for the cables to pass through. Thepericardium (6) is a connective-tissue-type sac surrounding the heart(61), and which, due to a narrow lubricant layer, gives the heart (61)the ability to move freely. As a lubricant, it contains a serous fluid,also called liquor pericardii. In order to prevent this lubricant fromescaping from the pericardium (6) through the cable opening, and toprevent any other fluids or solids (like, for example, cells, proteins,foreign matter, etc.) from entering the pericardium (6), a pericardiumseal (5) can be installed around the cable (4). The pericardium seal (5)seals the opening of the pericardium (6) to the cable (4). Thepericardium seal (5) can include a first sealing component with a firstsealing lip, and a second sealing component with a second sealing lip. Acable (4) can be routed through a central lumen of the seal. The firstsealing lip and/or the second sealing lip can seal the pericardiumopening. Located inside the central lumen can be an additional sealingcomponent, which seals the cable (4) against the pericardium seal (5)and, if necessary, fixes it as well. The first and the second sealingcomponent can be combined. Preferably, the first and the second sealingcomponent can be secured with a mechanism. Possible mechanisms to securethe sealing components are screw mechanisms, clamping mechanisms, or abayonet mechanism. The first sealing component and/or the second sealingcomponent can be expandable, or even self-expanding. The pericardiumseal (5) is explained in greater detail in a later section of thedescription.

FIGS. 4 a and 4 b show a cross-section of the heart (61) and part of thedevice for the support of the cardiac function (61) along line A-A inFIG. 3. Starting from the outside to the inside, the following layersare represented: The sheath (2) with a membrane (21), a sleeve (7) withat least one expandable unit (71, 72), a sleeve (80) with at least onesensor (81) or one electrode (82), and a transverse cross-section of theheart (60). Three augmentation units (71) and three positioning units(72) are illustrated as examples. In FIG. 4 a, the expandable units (71,72) have been drawn in the non-expanded state. In FIG. 4 b, theaugmentation units (71) have been drawn in the expanded state. Theexpandable unit (71, 72) is located in an area adjacent to a ventricle.An expansion of the expandable unit (71, 72) can reduce the volume ofthe ventricle and cause blood to be ejected from the ventricularchamber. The sensor (81) or the electrode (82) is installed in aparticular location, where at least one parameter of the heart (61) canbe measured. An electrode (82) can be installed in a particularlocation, where the myocardium can be stimulated. In FIGS. 4 a and 4 b,four sensors (81) in the sleeve (80) and three electrodes (82) at theinside of the sleeve (80) are illustrated as examples.

FIG. 5 shows a delivery system (100), which can be used to implant thedevice to support the cardiac function. The delivery system (100)includes a catheter (103), which has a lumen. Preferably, the catheter(103) is an elongated, tubular component, into which the device for thesupport of the cardiac function can be inserted in its compressed state.The cross-section of the catheter (103) and/or of the lumen can becircular, oval or polygonal. The delivery system (100) can furtherinclude a guide wire (101) and/or a dilatation component. The dilatationcomponent can be soft cone-shaped tip (102) with a shaft. The guide wire(101) can be passed through a puncture of the chest wall (65) betweenthe ribs (64) and of the pericardium (6). The soft, cone-shaped tip(102) can have at the center a circular, oval or polygonal lumen. Thesoft, cone-shaped tip (102) can be pushed over the guide wire (101) andthe puncture can be dilated without injury to the epicardium. The distalsection of the catheter (103) of the delivery system (100) can be passedthrough the dilated opening. At the distal end of the catheter (103), afirst sealing component (51, 52) of the pericardium seal can be snappedon or otherwise attached. The catheter (103) may, for example, be pushedonto a cone (55) located at the end of the first sealing component (51,52). Not shown is another embodiment, where a cone is located at theside of the catheter, onto which the first sealing component can bepushed. The catheter (103) with the attached first sealing component(51, 52) of the pericardium seal can be guided via the shaft of the softtip (102) and inserted into the pericardium (6).

Alternatively, the catheter (103) and the first sealing component (51,52) of the pericardium seal can be parts that are not interconnected toeach other. In this case, the catheter (103) is initially inserted intothe pericardium (6), and the first sealing component (51, 52) can thenbe pushed into the pericardium via the catheter or withdrawn from thepericardium (6) through the lumen of the catheter (103). The firstsealing component (51, 52) can be a self-expanding sealing component,and is configured to unfold inside the pericardium (6). Alternatively, anon-expandable part (51) of the first sealing component contains aself-expanding sealing lip (52) or a sealing lip (52), which isconfigured to fold down while the first seal component (51, 52) is beinginserted, and which opens up inside the pericardium (6). The firstsealing component (51, 52) can expand into a mushroom or umbrella-likeshape.

A second sealing component (53, 54) can be inserted along the catheter(103) or through the catheter (103). For example, the second sealingcomponent (53, 54) can be moved via the catheter (103) of the deliverysystem (100) to the distal end of the delivery system (100), and thencoupled with the first sealing component (51, 52). The second sealingcomponent (53, 54) can be expandable or non-expandable. The secondsealing component (53, 54) can be coupled to the first sealing component(51, 52). The second sealing component (51, 52) is preferablyself-expanding, and can in its expanded form assume the shape of amushroom or an umbrella. The second sealing component (53, 54) can besecured with the first sealing component (51, 52). Shown in FIG. 5 is ascrew mechanism. Other mechanisms to secure the sealing components (51,52, 53, 54) include a clamping mechanism or a bayonet seal. Aftersecuring the sealing components (51, 52, 53, 54), the catheter (103) ofthe delivery system (100) can remain on the cone (55) of the firstsealing component (51) or remain in the lumen of the sealing component(51, 52). After the guide wire (101) and the shaft of the soft tip (102)have been pulled out of the catheter, the shell with the sensor or theelectrode and/or with the expandable unit can be inserted through thelumen of the catheter (103). The sheath is preferably self-expanding andat least partially encloses the heart (61) after expansion. Located atthe lower end of the sheath can be a connector or a cable with aconnector. The supply unit can be directly attached to the sheath, or beconnected to the sheath via a cable. After the sheath has beendelivered, the delivery system (100) can be removed. The delivery system(100) is detached from the sheath by using a pre-weakened breaking point(104) of the delivery system (100) and/or on the catheter (103).Preferably, there are one or multiple pre-weakened breaking points (104)along a longitudinal axis of the delivery system (100). The pre-weakenedbreaking point (104) can be represented by a breaking line. When thedelivery system (100) is broken open along a pre-weakened breaking point(104), the delivery system (100) can be split, unrolled and removed. Thedelivery system (100) can also include grasping components (105), whichcan be used to apply a force to the delivery system (100). Preferably,the grasping components (105) can be used to apply a force directedsideways from the catheter (103) onto the delivery system (100) suitableto break open the pre-weakened breaking point (104).

The delivery system (100) can further include a sensor (107). The sensorcan be a temperature sensor (107) to measure the temperature within thecatheter before and during the implantation of the sheath. Thetemperature sensor (107) can include a thermocouple, a crystaloscillator or an infrared camera. Alternatively, the sensor can be asensor to measure at least one of the temperature, pH-value, osmolarityand oxygen saturation of a fluid within the catheter. The wall of thecatheter (103) can further contain heating elements (108).

The heating elements (108) can be used to heat the catheter (103) andits content before or during implantation. The delivery system (100) cancontain one, two, three, four or more heating elements (108). Theheating elements (108) can be arranged along the circumference of thecatheter wall (103) equidistantly or irregularly. The heating elements(108) can span the whole length of the catheter (103) or cover thelength of the catheter only partially. The heating elements (108) can beadjacent to the catheter wall (103) at the inside or the outside or theycan be within the catheter wall.

The heating elements (108) can include heating filaments, heating coilsor heating wires, which produce heat via an electrical current. Theheating elements (108) can further consist of ducts within the catheterwall that are perfused by a tempered fluid. The catheter can be heatedby using a perfusion fluid whose temperature is higher than the ambienttemperature. The ducts can also be perfused by a fluid whose temperatureis lower than the ambient temperature, in this way the ducts areutilized to cool down the catheter and its content to a lowertemperature. With a temperature sensor and the heating elements, thetemperature within the catheter can be maintained at a specific levelbetween −5° C. and +40° C.

FIG. 6 shows a step of the implantation of the device. After the firstsealing component (51, 52) in the pericardium (6) has assumed theexpanded form, the sheath (2), which is preferably self-expanding, canbe passed through the lumen of the catheter (103) of the delivery systemand lumen of the first sealing component (51). After entering throughthe pericardium seal, the sheath (2) with the sensor or the electrodeand/or the expandable unit expands inside the pericardium (6).

Shown in FIG. 6 is also the second sealing component (58, 59) beforebeing coupled with the first sealing component (51, 52). In thisembodiment, the second sealing component (58, 59) is a ring-shapedcomponent (58), e.g., a nut, on which a sealing disk (59) can beattached to its distal side. The second sealing component (58, 59) canbe expandable or non-expandable. The second sealing component (58, 59)can be moved on the catheter (103). In this embodiment, the firstsealing component (51, 52) the sheath with the sensor or the electrodeand/or with the expandable unit can be inserted through the lumen andthe second sealing component (58, 59) exhibit thread sections, which canbe screwed together.

FIG. 7 shows a step of the implantation of the device. In thisembodiment, the first sealing component (51, 52) is coupled with thesecond sealing component (53). The pericardium (6) can thereby besealed. The expandable sheath (2) is partially located inside thepericardium (6) and can be expanded. FIG. 7 shows markings (22, 23, 24)applied to the sheath (2). The device generally contains at least onemarking (22, 23, 24), which can facilitate the correct placement of thesheath (2). The marking (22, 23, 24) can be a visual mark, in particulara color marking. The marking (22, 23, 24) can be a phosphorescent orfluorescent marking, making it easier to see in dark environment. Suchenvironments can be present in the operating room itself, and can alsobe caused by the casting of shadows. Such environments can also beinside the body of a patient. The marking (22, 23, 24) can be made of amaterial able to be represented by imaging techniques. Suitable imagingtechniques include X-rays, CT-methods, and MRI-methods. For example, themarking (22, 23, 24) can be formed of a more radiopaque material thanthe material of adjacent regions. The marking (22, 23, 24) can have theform of a point, a circle, an oval, a polygon, or the form of a letter.Other forms can be areas created by the connecting of dots. The form canbe, for example, a half-moon or a star. The marking (22, 23, 24) can beapplied to the sheath (2) or applied to a sleeve. The marking can beapplied in the form of a line. The line can start at the upper edge ofthe sheath (2). The line can run from an upper edge of the sheath (2) toa point at the lower tip of the sheath (2). The line can run from theupper edge of the sheath perpendicular to the lower tip of the sheath(2). The starting point of the line at the upper edge of the sheath (2)can be located at a place, which in the implanted state is close to anarea, or at an area, which is level with the cardiac septum. The marking(22, 23, 24) can be located at crossing points of the mesh or thelattice. If the sheath (2) includes a sheath sleeve, into which holeswere formed, the marking (22, 23, 24) can be worked into the sheathsleeve. For example, a hole can be manufactured with a predefined form,which then serves as marking (22, 23, 24).

The delivery system and/or the catheter (103) of the delivery system caninclude one or multiple markings (106). A marking (106) on a deliverysystem can be formed like a marking on a sheath. The marking (106) canhave the form of a dot or the form of a line. A marking (106) in theform of a line can be a line, which at least partially describes acircumference of the delivery system. A marking (106) in the form of aline can be a longitudinal line along an axis of the delivery system. Amarking (106) in the form of line can be a straight line or a meanderingline. A marking (106) in the form of a line can be a line runningdiagonally on a catheter (103) of a delivery system. A marking (106) canfacilitate the orientation of the delivery system during implantation. Amarking (106) at or on the delivery system can be in alignment with aline at or on a medical implant. For example, the medical implant can bea device for the support of the cardiac function, which can becompressed. In a compressed state, the device can be inserted into adelivery system. One or multiple markings (22, 23, 24) on or at thedevice can be aligned with one or multiple markings (106) on or at thedelivery system. Such markings (22, 23, 24, 106) facilitate theorientation of a medical implant. Markings (22, 23, 24) can also belocated along an axis of a medical implant. Such markings (22, 23, 24)can be helpful in tracking the progress of the discharge of a medicalimplant out of the delivery system. The delivery system and/or acatheter (103) can be made of a transparent material, which allows themedical implant to be visually traceable during insertion.

FIG. 8 shows a step of the implantation of the device. In this example,the first sealing component (51, 52) and the second sealing component(53) of the pericardium seal are interconnected. The device for thesupport of the cardiac function has already been partially dischargedfrom the delivery system. Shown is a self-expanding sheath (2). In thisembodiment, the sheath (2) is formed from a wire mesh exhibiting loops(26, 28) at the upper edge and/or at the lower edge of the sheath (2).The sheath (2) can also be formed of a lattice structure and can exhibitlinks in the form of straps at the upper edge and/or at the lower edgeof the sheath (2). If the sheath (2) is formed from a sheath sleeve,into which holes have been formed, the upper edge and/or the lower edgeof the sheath (2) can be designed such that at least one strap islocated at the upper and/or lower edge of the sheath (2). The sheath (2)represented in FIG. 8 includes a sleeve (80), which is inserted into thesheath (2). Another sleeve including at least one expandable unit can belocated between the sleeve (80) and the sheath (2).

One or both sleeves can be fastened to the loops (26, 28) or straps ofthe sheath (2). A sleeve can, in particular, be hooked onto the loops(26, 28) or the straps of the sheath (2). In such case, the sleeve (80)can exhibit at least one pocket (27), which can be pulled over at leastone loop (26, 28) or at least one strap. Another embodiment can includea sleeve (80), which is turned inside out at its upper edge and/or atits lower edge. This inversion can form a pocket (27) around the entiresleeve (80) or around a part thereof, which can be hooked into the upperedge and/or the lower edge of the sheath (2). In FIG. 8, the sheath (2)exhibits multiple markings (22, 23, 24, 25). As previously described,these markings (22, 23, 24, 25) can assume different forms or positions.In this case, the markings (22, 23, 24, 25) are attached to the upperedge and the lower tip of the sheath (2).

FIGS. 9 a-c show different views of a pericardium seal (5). Thepericardium seal (5) serves to prevent the loss of pericardium fluid oralso as an option to apply artificial pericardium fluid, medications orother therapeutics. The prevention of loss of pericardium fluid alsoserves to prevent adhesions of the system with the epicardium. Thepericardium seal (5) generally includes a first sealing component (51)and a second sealing component (52). The first sealing component (51)has a central lumen, and the second sealing component (53) has a centrallumen. The first sealing component (51) can be coupled with the secondsealing component (53). After coupling the first sealing component (51)to the second sealing component (52), the pericardium seal (5) exhibitsa lumen running through the pericardium seal (5). The lumen can beformed exclusively by the central lumen of the first sealing component(51), or the lumen can be formed exclusively by the central lumen of thesecond sealing component (53). In another embodiment, the lumen can alsobe formed from both lumens of the two coupled sealing components (51,53). Located in the lumen can be a sealing gasket, an O-ring, alabyrinth seal or another sealing component (56). A sealing component(56) in the lumen of the pericardium seal can seal the pericardium seal(5) against an object protruding through the pericardium seal (5). Forexample, a cable can be passed through the pericardium seal (5), whichis then sealed against the pericardium seal (5). A sealing component(56) in the lumen can serve not only to seal but also to fix an objectprotruding through the lumen of the pericardium seal. The sealingcomponent (56) can be attached to both sealing components (51, 53) or toone of both sealing components (51, 53) only.

Using a mechanism, the first sealing component (51) can be secured withthe second sealing component (53). A mechanism to secure a first sealingcomponent (51) with a second sealing component (53) can include a screwmechanism or clamping mechanism. A mechanism to secure a first sealingcomponent (51) with a second sealing component (53) can also include abayonet catch. The first sealing component (51) and the second sealingcomponent (53) can be made of the same material or made of differentmaterials. Suitable materials for the first sealing component (51)and/or the second sealing component (53) include synthetic materials,metals, ceramics or combinations thereof.

Attached to the first sealing component (51) can be a first sealing lip(52). The first sealing lip (52) can be part of the first sealingcomponent (51) or can be attached to the first sealing component (51).Attached to the second sealing component (53) can be a second sealinglip (54). The second sealing lip (54) can be part of the second sealingcomponent (53) or can be attached to the second sealing component (53).The first sealing lip (52) and the second sealing lip (54) can be formedof the same material or of different materials. One or both sealing lips(52, 54) can be part of the respective sealing component (51, 53) andcan be formed from the same material as the associated sealing component(51, 53). The first sealing lip (52) and/or the second sealing lip (54)can be formed of a synthetic material (preferably of an elastomer),natural rubber, rubber, silicon, latex or a combination thereof. Thefirst sealing lip (52) and/or the second sealing lip (54) can bedisk-shaped. The first sealing lip (52) and/or the second sealing lip(54) can exhibit a concave or a convex curvature. Curved sealing lips(52, 54) can better adapt to anatomic conditions. The pericardiumexhibits a convex form in the area of the cardiac apex. With the sealinglips (52, 54) exhibiting a curvature in the shape of the anatomicallyavailable form, an improved anatomic fit of the pericardium seal (5) canbe achieved.

Curved sealing lips (52, 54) can also be used to achieve better sealingproperties. The first sealing lip (52) and/or the second sealing lip(54) can have reinforcements. With increasing radial distance from thelumen of the pericardium seal towards the outside, the first sealing lip(52) and/or the second sealing lip (54) can exhibit increasedflexibility. Increased flexibility at the edges of sealing lip (52, 54)can strengthen the sealing properties of the sealing lip (52, 54) andcan also support the anatomically correct positioning of the sealing lip(52, 54). Increased flexibility at the edges of the sealing lip (52, 54)can be achieved through the choice of material. Each sealing lip (52,54) can be made of one material or of multiple materials. Reinforcementsof a sealing lip (52, 54) can be concentric reinforcements or radialreinforcements. Reinforcements can be achieved by means of variablematerial thicknesses or by introduction of a reinforcing material. Thereinforcing material can be the same material as the base material ofthe sealing lip (52, 54), having been converted into a different form ofthe material. Alternatively, regions, that are not to be reinforced canbe weakened by converting the material of the sealing lip (52, 54) intoa weaker form of the material. A weakening of the material can beinduced by exposure to energetic radiation (e.g., heat). Reinforcementsof the material can also be achieved by application of material, wherebythe applied material can be the same material as the base material ofthe sealing lip (52, 54), or whereby the applied material can be amaterial different from the base material of the sealing lip (52, 54).Suitable materials for the reinforcement of sections of a sealing lip(52, 54) are metals, ceramics, rubber, or a combination thereof.

One of the two sealing components (51, 53) can exhibit a couplingmechanism, allowing the coupling of a sealing component (51, 53) withthe delivery system or a catheter of the delivery system. The couplingmechanism can consist, for example, of a cone (55) located at the firstsealing component (51), onto which the delivery system or a catheter ofa delivery system can be clamped. The clamping effect can be achieved bythe diameter of the cone (55) being larger than the luminal diameter ofthe delivery system, for example. The coupling mechanism to couple thepericardium seal (5) to the delivery system can also be available at thesecond sealing component (53). The coupling mechanism can also beprovided as a separate part in addition to the sealing components (51,53), and can link the delivery system to one of the two sealingcomponents (51, 53) of the pericardium seal (5). Other embodiments ofthe coupling mechanism may include, among others, a non-conical (e.g.,cylindrical) extension on one of the sealing components (51, 53), ontowhich the delivery system can be placed or glued. In some embodiments,the catheter of the delivery system and a sealing component form asingle integrated part. In some embodiments, the catheter can aftersuccessful insertion and securing of the pericardium seal (5) bedisconnected from the sealing component (51, 53) or the pericardium seal(5) by means of a pre-weakened breaking point.

One or both sealing components (51, 53) can exhibit engaging components(57). These engaging components (57) can be used to apply a force to oneor both sealing components (51, 53) appropriate to couple and/or securethe sealing components (51, 53). Engaging components (57) on one or onboth sealing components (51, 53) can be holes, indentations orelevations. The engaging components (57) can be installed around thecircumference of the sealing component (51, 53) at an equal distancefrom each other. The circumferential distance between the engagingcomponents (57) can also vary. FIGS. 9 a-c illustrate six engagingcomponents (57) equidistantly disposed around the circumference. On thering-shaped sealing component (53), the six engaging components (57) areinstalled at an angular distance of approximately 60°. In the case oftwo, three, four, five, six, eight or more evenly distributed engagingcomponents (57), the angular distance is 180°, 120°, 90°, 72°, 60°, 45°or less, respectively. The engaging components (57) can also beinstalled in an unevenly spaced configuration.

FIG. 10 shows a pericardium seal (5) and a tool (11) to secure apericardium seal (5). The pericardium seal (5) shown in FIG. 10 isessentially identical to the seal shown in FIG. 9. As an example, thetool (11) is represented as an elongated tubular tool. Located at thedistal end of the tool (11) are components (111), which can be at leastpartially engaged with the engaging components (57) of a sealingcomponent (53). In the embodiment shown in FIG. 10, the inside of thetubular tool (11) exhibits at the distal end six elevations (111)pointing to the inside, which can engage with the six engagingcomponents (57) of the sealing component (53), for example, with sixindentations on the sealing component (53). The tool (11) essentiallyexhibits the same number of components (11), which are complementary tothe engaging components (57) of the sealing component (53). The tool(11) shown in FIG. 10 is a tubular tool, consisting of a complete tube.The tubular component of the tool (11) can also be half a tube, aquarter tube, or a third of a tube. In the extreme case, instead of thetube, only one shaft or multiple shafts can be attached to a distal,ring-shaped tool. A shaft can extend from the ring-shaped tool inlongitudinal direction. A shaft can also extend laterally away from alongitudinal axis of the tool. Other embodiments of the tool (11) (notshown) can be provided in the form of a modified box wrench or amodified open-end wrench.

FIG. 11 shows a connector system consisting of two connectors (90, 92).The device for the support of the cardiac function includes a sheathwith at least one sensor or at least one electrode and/or at least oneexpandable unit, whereby the sensor or electrode and/or the expandableunit are connected to a supply unit. The sensor or the electrode and/orthe expandable unit can be directly connected to the supply unit. Thesensor or the electrode and/or the expandable unit can be connected tothe supply unit via a cable (4). The sensor or the electrode and/or theexpandable unit can be directly linked to the supply unit via the cable(4), or the sensor or the electrode and/or the expandable unit can beconnected to the supply unit. The supply unit can include a connector(92). The connector (92) can be attached directly to the supply unit.The connector (92) can be connected to the supply unit via a cable (4).The sensor or the electrode and/or the expandable unit can include acable (4). At the end of the cable (4) can be a connector (90). Theconnector (90) at the end of the cable of the sensor or of theexpandable unit matches the connector (92) at the supply unit. Theconnector (90) of the sensor or of the electrode and/or the expandableunit can be a male or a female connector. A female connector on the sideof the sensor or the electrode and/or the expandable unit can beadvantageous, since the female connector in contrast to the maleconnector does not include any pins (951) or any other terminals, whichcan protrude and therefore could break. If an exchange of the supplyunit is required, the connector system is disconnected, and a new supplyunit is connected to the connector (90) of the sensor or the electrodeand/or the at least expandable unit. The reconnection of the connector(90) with a supply unit might cause pins (951) or other terminals tobreak. If the pins (951) or terminals are located in a male connector onthe side of the sheath with the sensor or the at last one electrodeand/or the expandable unit, an exchange of the sheath may be required. Afemale connector on the side of the sheath with the sensor or theelectrode and/or the expandable unit can be advantageous, since thebreaking of pins (951) or other terminals cannot occur at a femaleconnector. The connector system (90, 92) usually includes twoconnectors. The device can consist of a connector system (90, 92) forthe sensor or the electrode and/or the expandable unit, or of multipleconnector systems. If multiple connector systems are used, a connectorsystem for electrical leads and a connector system for hydraulic and/orpneumatic lines can be provided. The connector system (90, 92)represented in FIG. 11 is a connector system consisting of connectionsto supply the sensor or the electrode and the expandable unit. Thenumber of connections depends on how many sensors or electrodes and howmany expandable units are being used. In some implementations, thenumber does not necessarily have to correlate directly with the numberof sensors or electrodes and/or the number of expandable units. Splitleads/lines on both sides of the connector system (90, 92) are possible,and a pneumatic or hydraulic line is configured to supply one, two,three, four, five, six or more fillable chambers. The filling of themultiple chambers by one line does not have to occur simultaneously; itcan also occur individually by means of individually controllablevalves. Likewise, one electrical lead inside the cable can be used formultiple sensors or electrodes, and switches can individually energizecircuits. The connector system (90, 92) represented in FIG. 11 includesfour hydraulic or pneumatic connection ports (93, 94) and one connectionfor electrical leads (95, 96). The connecting port for electrical leads(95, 96) shown in FIG. 11 exhibits 16 connecting components in the formof pins (951) and pin sockets (961). More or fewer connections forelectrical leads (95, 96) and/or pneumatic or hydraulic lines (93, 94)can exist in one connector system. The pneumatic or hydraulic lines (93,94) can include one, two, three, four, five, six, seven, eight, nine orten connections.

The electric leads (95, 96) can include one, two, three, four, five,six, seven, eight, nine, ten, twelve, fourteen, sixteen, twenty or moreconnections. One electrical connector for electric leads (95, 96) canhave one, two, three, four, five, six, seven, eight, nine, ten, twelve,fourteen, sixteen, twenty or more connecting components in the form ofpins (951) and pin sockets (961). The number of connecting components inthe form of pins (951) and pin sockets (961), however, is identical forthe respective pair of connections for electricals leads (95, 96). Eachof the connections (93, 94, 95, 96) in one or in both of the connectorsof the connector systems (90, 92) can have its own seal (931, 952). Theseal (931, 952) of the individual connections (93, 94, 95, 96) can be asealing tape or a sealing gasket. The connector system (90, 92) can inaddition or only one seal inside the connector system (973) or aroundthe connector system. A seal via the connector system can be a sealingtape or a sealing gasket. The connector parts (90, 92) can beinterconnected in order to create the connector system (90, 92). Theconnector parts (90, 92) can have a guide peg (972) and a guide slot(974). The guide peg (972) and the guide slot (974) can prevent wrongconnection of the two connector parts and/or turning the connector partsthe wrong way during connection. The connector parts (90, 92) can alsoinclude two, three, or more guide pegs (972) and guide slots (974). Inthe case of two or more guide pegs (972) and guide slots (974), unequaldistances between the individual guide pegs (972) and guide slots (974)can be used. The interconnected connector parts (90, 92) can also besecured with a mechanism (971). Such mechanism (971) can be a screwingmechanism or a clamping mechanism or a bayonet catch. A mechanism tosecure the interconnected connector system (90, 92) can also be aretainer nut, a clamp, a latch or a snap-lock mechanism. Securing theconnector system (90, 92) is advantageous, since any accidental partialor complete disconnection of the connector system (90, 92) can interruptthe supply of the sensor or the at least one electrode and/or theexpandable unit.

FIG. 12 shows a model for the preparation of a system of coordinates.The development of a system of coordinates can facilitate themanufacture of a device for the support of the cardiac function, sincethe position for the sensor or one electrode and/or the expandable unitand/or the marking can be exactly defined. FIG. 12 a shows a heart (61)with anatomical points of reference. The example illustrates the heart(61) with the aortic arch (AO) originating at the left ventricle (LV)(with head arteries, neck arteries, and subclavian arteries (TR, CL,SCL) branching off), and the pulmonary artery (PU) originating at theright ventricle (RV). Also shown are sections of the inferior vena cava(IVC) and the superior vena cava (SVC). The broken line (601) representsthe height of the valve plane. The point (604) of the cardiac apex isdefined by letting a perpendicular (603) fall from this plane (601)through the most distal point of the cardiac apex. The device includes asheath, into which a sleeve with at least one sensor or one electrodeand/or a sleeve with at least one expandable unit can be inserted. Thedimension of the sheath and/or the sleeve can be designed such that theupper edge of the sleeve (602) runs parallel to the valve plane with adownward offset in the direction of the cardiac apex at a distance fromthe valve plane of 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm,preferably 5 mm. The upper edge of the sheath is shown by the line (602)in FIG. 12 a. The lower edge of the sheath (605) and/or the sleeve canbe parallel to the valve plane with a distance to the most distal point(604) of 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm, preferably 5 mm.FIG. 12 b shows a cutting plane B-B along the line (602) shown in FIG.12 a, i.e., along the line corresponding to the upper edge of thesheath.

FIG. 12 b shows the right ventricular chamber (RV) and the leftventricular chamber (LV), the heart wall and the septal wall separatingthe cardiac chambers. The points (608) and (609) are defined as thepoints of intersection of the centerlines of the heart wall with theseptal wall. The point (608) is also called the anterior intersectingpoint of the centerlines of the heart wall with the septal wall. Thepoint (609) is also called the posterior intersecting point of thecenterlines of the heart wall with the septal wall. The center point ona line connecting points (608) and (609) is defined as point (607).These points can be used to define a system of polar coordinates. Thez-axis (606) of the polar coordinate system is defined as the lineconnecting the most distal point (604) to the center point (607) of theline connecting points (608) and (609). The circumferential direction ofthe coordinate system is suggested by the reference numeral (610) anddefined as angle measure φ, whereby a line radially running from thez-axis (606) through the anterior point of intersection (608) is definedas φ=0°.

FIG. 13 shows a sheath and/or sleeve with the coordinate systemdescribed above in conjunction with FIG. 12. FIG. 13 a shows a 3D-model(611) of a sheath or sleeve with the z-axis (606) extending through themost distal point (604) and the center point (607) of the lineconnecting points (608) with (609). The points (608) and (609) are theanterior and the posterior point of intersection of the center lines ofthe heart wall with the septal wall, whereby the φ=0° line is drawnthrough the point (608). The broken line connecting the points (608) and(609) along an outer circumference of the sheath or the sleeve,represents the position of the septal wall of the heart as projectedonto the sheath/sleeve. At the upper edge of the sheath or the sleeve,the angle measures starting at φ=0° are shown in 30° increments,whereby—viewed from above—the angles increase counterclockwise.Longitudinal lines (613) projected onto the sheath/sleeve respectivelyextend along these angles up to the cardiac apex (604). The anglemeasure of φ=360° then again corresponds to the angle measure of φ=0°.Contour lines (614) are indicated at distances of 15 mm increments. Thecontour lines (614) and planes are running perpendicular to the z-axis(606). The broken-dotted line (615) constitutes a cutting line, wherethe 3D shape (611) can be cut open and rolled out. FIG. 13 b shows arolled-out sheath or sleeve (612), which has been cut along the line(615) in FIG. 13 a and then rolled out. The positions (608, 609) andlines (613, 614, 615, 616) shown in FIG. 13 b represent the samepositions and lines that are shown in FIG. 13 a.

FIG. 14 shows a sleeve (7) with at least one expandable unit (71, 72).The 3D-shape of the sleeve (7) in FIG. 14 a is comparable to the3D-model explained in conjunction with FIG. 13 a and shows a coordinatesystem as described above. The sleeve (7) can at least partially enclosea heart. The sleeve (7) can at least partially have the shape of aheart. The sleeve (7) can have a shape similar to the sheath. The sleevecan be inserted into the sheath. The sleeve can be made of syntheticmaterial, polymer, natural rubber, rubber, latex, silicon orpolyurethane.

In FIG. 14 a, the sleeve (7) with at least one expandable unit (71, 72)is shown as a sleeve (7) with a multiplicity of chambers. FIG. 14 bshows a 2D-rollout of the 3D-model from FIG. 14 a. The rolloutrepresented in FIG. 14 b is essentially identical to the rollout of a3D-model explained in conjunction with FIG. 13 b. Unlike in FIG. 13 a,the 3D-model in FIG. 14 a is rotated such that a view from above intothe sleeve (7) is possible. In FIGS. 14 a and 14 b, four expandableunits (71, 72) are shown as examples, three of which are augmentationunits (71) and one is a positioning unit (72). The expandable units (71,72) can be structurally similar but can serve different purposes, asdescribed above.

Generally, an augmentation unit (71) can be periodically expanded andrelaxed in order to be configured to apply pressure to the heart. Thispressure is preferably applied in ventricular areas. By applyingpressure to a ventricle via the augmentation unit (71) the naturalpumping motion of the heart is supported or substituted, and the bloodinside the ventricular chamber is pumped into the corresponding artery.A pressure applied by an augmentation unit (71) to a right ventricleleads to the blood being ejected from the right ventricle into thepulmonary artery. A pressure applied by an augmentation unit (71) to aleft ventricle leads to the blood being ejected from the left ventricleinto the aorta.

FIG. 14 shows three augmentation units (71), which are located at theupper edge of the sleeve (7). In this example, each of the augmentationunits (71) is supplied by its own line (41).

In the case of augmentation units (71) in the form of inflatablechamber, the lines (41) are preferably pneumatic or hydraulic lines.Other embodiments include one, two, three, four, five, six or moreaugmentation units (71), which are supplied by one, two, three, four,five, six or more lines (41). The line (41) can be made of syntheticmaterial, polymer, natural rubber, rubber, latex, silicon, orpolyurethane. The line (41) can run above, adjacent to or below theaugmentation unit (71). The line (41) can preferably run below apositioning unit (72), so that no pressure points result between theline (41) and the heart wall. The line (41) can also run above oradjacent to a positioning unit (72).

The augmentation units (71) A1, A2, and A3 shown in FIG. 14 are locatedin an area at the upper edge of the sleeve (7) and are each supplied bytheir own respective line (41). The augmentation units (71) A1 and A2can—as illustrated in FIG. 14—be positioned such that they can assist aleft ventricle. Augmentation unit (71) A3 is positioned to assist aright ventricle. The individual augmentation units (71) A1, A2 and A3can be expanded individually. Augmentation units (71) A1 and A2 canassist cardiac function for a heart with left ventricular insufficiency.Augmentation unit (71) A3 can serve to support a right ventricularinsufficiency.

Augmentation units (71) A1, A2 and A3 can be used for support of abilateral heart insufficiency. The augmentation units (71) can beexpanded synchronously or asynchronously. Preferably, the expansion ofthe augmentation units (71) can be coordinated such that a naturalpumping function of the heart is supported.

A positioning unit (72) is a unit, which can also be expanded.Preferably, a positioning unit is expanded during operation of thedevice for the support of the cardiac function more statically thanperiodically. The positioning unit (72) can be expanded in order to fixthe device to the heart and to optimize the accuracy of the fit of thedevice. A positioning unit (72) can also help to respond to changes ofthe myocardium. If the size of the myocardium decreases or increases, apositioning unit can be expanded or relaxed further in order to ensure aperfect fit.

FIG. 14 illustrates a positioning unit (72), which essentially fills thespaces between the three augmentation units (71) on the sleeve (7). Thepositioning unit (72) can have a distance from one or multipleaugmentation units (71) of 1 mm, 3 mm, 5 mm, 10 mm, 20 mm, 30 mm, 40 mmor more. The positioning unit (72) can be supplied by its own line (41),in the case of a chamber fillable with a fluid, by a pneumatic orhydraulic line. Other embodiments include one, two, three, four, five,six or more positioning units (72), which are supplied by one, two,three, four, five, six or more pneumatic or hydraulic lines (41). Theline (41) can consist of a synthetic material, polymer, natural rubber,rubber, latex, silicon or polyurethane. The line (41) for the supplyingof the positioning unit (72) can run below the positioning unit (72).The positioning unit (72), shown in FIG. 14, fills the spaces betweenthe augmentation units (71). The depicted positioning unit (72) hasextensions that protrude into the spaces between the augmentation units(71).

FIG. 15 shows an expandable unit (71, 72) in the form of a chamber(710). The depicted chamber is a bellows-shaped chamber (710). Abellows-shaped chamber (710) has at least one section in the form ofbellows. Preferably, chamber 710 is a folding bellows consisting of one,two, three, four, five, six, seven or more folds. An outwardly bent edge(711) can be defined as a fold. An inwardly bent edge (712) can bedefined as a fold. In some embodiments, the regions of the chamber wallbetween the folds are less stable than the folds. One, multiple or allbent edges (711, 712) can be reinforced. A reinforcement of a bent edge(711, 712) is advantageous, since the bent edge (711, 712) can beexposed to increased stress due to the expanding and relaxing of thechamber (710). A reinforcement of one or multiple bent edges (711, 712)can reduce or prevent material fatigue along the bent edge (711, 712).Reinforcement of a bent edge (711, 712) can be achieved through agreater wall thickness of the material at the bent edge (711, 712). Abent edge (711, 712) can also be reinforced through application ofadditional material, wherein the applied material can be the samematerial as the underlying material, or wherein the applied material canbe a different material than the underlying material. A chamber (710)can exhibit a top side (713), a bottom side and a side surface, wherebythe side surface is preferably designed in the shape of a bellows. Thetop (713) and/or the bottom side can be oval, circular, elliptical, orpolygonal. The top side (713) can have a different shape than the bottomside.

A bellows-shaped chamber (710) can be inserted into a sheath of the typedescribed above. The chamber (710) can be directly attached or fixedinside the sheath. The chamber (710) can be attached to structuralcomponents of the sheath, like, for example, a wire of a wire mesh, astrap of a latticework, or a structure on a sheath sleeve.

The chamber (710) can be attached to crossing points of a mesh orlatticework. The sheath can be covered by a membrane, as describedabove. In these cases, the chamber (710) can also be attached to themembrane. The membrane can also be a bottom side of the chamber (710).

The bellows-shaped chamber (710) can also be fastened to a sleeve (7).Multiple bellows-shaped chambers (710) can be fastened to a sleeve (7).The sleeve (7) can at least partially have the shape of a heart. Thesleeve (7) can have a shape similar to that of the sheath. The sleeve(7) can be inserted into the sheath. The sheath (7) can be fastenedand/or fixed inside the sheath. The sleeve (7) can, in addition to oneor multiple augmentation units like, for example, one or multiplebellows-shaped chambers (710), also exhibit one or multiple positioningunits. The bottom side of the chamber (710) can be made of the samematerial as the sleeve (7). The sleeve (7) can be part of the chamber(710). The sleeve (7) can form the bottom side of the chamber. In thosecases, only the lateral surfaces, which can be bellows-shaped, areapplied to a sleeve (7). In addition, a top side (713) can be attachedas well. The top side (713) can be a sleeve as well. Embodiments consistof two sleeves (7), whereby the sleeves (7) create the top side and thebottom side of the chambers, and lateral surfaces are formed between thesleeves. In this case, lateral surfaces can also be formed by joining,in particular by welding or gluing together of the two sleeves. Thesleeves (7) can be joined together, in particular, welded or gluedtogether, such that a chamber is formed. In some embodiments, thesleeves are connected to each other in a common edge region. In someembodiments, the chamber defines a gap of 0.1 mm to 5 mm. The linesupplying the chamber can be formed similar to the chamber at leastpartially by joining the two sleeves (7), in particular by welding orgluing together of the two sleeves (7). Located on one of the twosleeves (7) or on both sleeves (7) can be one or multiple sensors or oneor multiple electrodes.

The sleeve (7) with the expandable unit can at the upper edge and/or atthe lower edge exhibit at least one pocket. The pocket can be at leastpartially pulled over a structural shape of a sheath. The pocket can,for example, be at least partially pulled over a loop of a wire mesh ora strap of a latticework.

The sleeve (7) with the expandable unit can contain an active agent. Thesleeve (7) may, for example, contain an anti-thrombotic agent, ananti-proliferative agent, an anti-inflammatory agent, an anti-neoplasticagent, an anti-mitotic agent, an anti-microbial agent, a biofilmsynthesis inhibitor, an antibiotic agent, an antibody, ananticoagulative agent, a cholesterol-lowering agent, a beta blocker, ora combination thereof. The agent is preferably provided in the form of acoating on the sleeve (7). The sleeve (7) can also be coated withextra-cellular matrix proteins, in particular, fibronectin or collagen.

FIG. 16 shows a sleeve (80) with at least one sensor (81) and/or atleast one electrode (82). The 3D-shape of the sleeve (80) in FIG. 16 ais comparable to the 3D-model described in FIG. 13 a and shows acoordinate system as described above. The sleeve (80) can at leastpartially enclose a heart. The sleeve (80) can at least partially havethe shape of a heart. The sleeve (80) can have a shape similar to thatof the sheath. The sleeve (80) can be inserted into the sheath. Thesleeve (80) can be made of a synthetic material, polymer, naturalrubber, rubber, latex, silicon or polyurethane. The sleeve (80) canexhibit a thickness of 0.1 mm to 1 mm, preferably 0.2 mm to 0.5 mm. Thesleeve (80) with the sensor (81) and/or the electrode (82) can bepressed against the myocardium by the sleeve with the expandable units.The sleeve (80) can be coated, in particular, with a lubricant, whichreduces the friction between the myocardium and the sleeve (80) with thesensor (81) and/or the electrode (82). A coating, in particular, acoating with a lubricant can also be provided between the sleeve (80)with the sensor (81) and/or the electrode (82) and the sleeve with theexpandable unit. The sensor (81) and/or the electrode (82) can beworked, molded or welded into the sleeve (80) or attached, glued onto orsewn onto the sleeve (80). The sensor (81) and/or the electrode (82) canbe equipped with reinforcements configured to prevent bending during thecompression of the device.

In FIG. 16 a, the sleeve (80) is depicted with at least one sensor (81)and/or at least one electrode (82) as a sleeve (80) with a multiplicityof sensors (81) and electrodes (82). FIG. 16 b shows a 2D-rollout of the3D-model from FIG. 16 a. The rollout depicted in FIG. 16 b essentiallymatches the rollout of a 3D-model explained in conjunction with FIG. 13b. Unlike in FIG. 13 a, the 3D-model in FIG. 16 a is rotated to allow aview from above into the sleeve (80). In FIGS. 16 a and 16 b, eightsensors (81) or electrodes (82) are shown as examples. Other embodimentscan include one, two, three, four, five, six, seven, eight, nine, ten,eleven, twelve or more sensors (81) and/or electrodes (82). The sleeve(80) with the sensor (81) or at least one electrode (82) can be a net ofsensors (81) or electrodes (82). The net of sensors (81) or electrodes(82) can at least partially enclose the heart. The sensors (81) orelectrodes (82) in the net of sensors (81) or electrodes (82) can beinterconnected. The sleeve (80) can function as the carrier of the netof sensors (81) or electrodes (82). The net of sensors (81) orelectrodes (82) can also be only partially attached to a sleeve (80).The net of sensors (81) or electrodes (82) can also be inserted withouta sleeve (80) into a sheath as the one described above.

The sensor (81) or the electrode (82) can determine a physical or achemical property of its environment. The property can be detectedqualitatively or quantitatively. The sensor (81) can be an active sensoror a passive sensor. The sensor (81) can detect at least one parameterof the heart. The sensor (81) can be configured to determine the heartrate, the ventricular pressure, the systolic blood pressure, thediastolic blood pressure, pressure applied to a surface of the heart,fluid presence, acidity, electrical resistance, osmolarity, oxygensaturation or flow through a vessel. The sensor (81) can be configuredto measure the pressure applied by an expandable unit onto a surface,the pH-value, the electric resistance, the osmolarity of a solution, orthe flow through a vessel. The sensor can also be used as an electrode.

The electrode (82) can be configured to electrically stimulate areas ofthe heart and/or to measure the electrical activity at the epicardiumduring the excitation process. The electrode (82) can be configured tostimulate the myocardium with the use of electrical impulses. Anelectrical stimulation can induce a myocardium to contract. Theelectrode (82) can be a pacemaker electrode. The electrode (82) can bean extra-cardial stimulation electrode. With an electrode (82), themyocardium can be stimulated before, during or after a support of thepumping function of the heart by a sheath with at least one expandableunit. The expansion of an expandable unit can occur before, during orafter stimulation with an electrode (82). The device for the support ofthe cardiac function can be operated only with at least one expandableunit or only through stimulation with at least one electrode (82).Simultaneous operation of the expandable unit and the electrode (82) canbe synchronous or asynchronous. The electrode can also be used a sensor.

The sensor (81) or the electrode (82) can be fastened to the sleeve(80). The sensor (81) or the at least one electrode (82) can be glued,sewed or welded to the sleeve (80). The sensor (81) or the electrode(82) can be attached to the inside of the sleeve (80), preferably weldedin. The sensor (81) or the electrode (82) can be connected via a lead(84) to a supply unit. The data detected by the sensor (81) or theelectrode (82) can be transmitted connectionless via wirelesstechnology, like bluetooth, for example.

The contacts of the electrodes or sensors or the entire sleeve can becoated with a substance, which increases or improves conductivity. Agraphite coating on the contacts, for example, can increase theirconductivity.

Example #1

FIG. 17 shows an embodiment of a sleeve (7) with at least one expandableunit (71, 72). FIG. 17 depicts a 2D-rollout of a 3D-model described inconjunction with FIG. 13. The illustrated sheath includes threeaugmentation units (71) (A1, A2, A3) and a positioning unit (72) (P). Insome embodiments, the augmentation units A1 and A2 each occupy an areaof 28.6 cm² on the sleeve. The area occupied by augmentation unit A3 inthis example is 34.5 cm². The positioning unit (72) (P) occupies an area114.5 cm². Under normal conditions, the nominal expansion of thepositioning unit (P) is 5 mm (e.g., the positioning unit is partiallyexpanded and exhibits a thickness of 5 mm). The positioning unit can bea chamber, which can be filled and unfilled with a fluid. The thicknessof the positioning unit can therefore be between 1 mm and 10 mm,preferably between 3 mm and 7 mm. By changing the thickness of thepositioning unit (72) (P) an increase or decrease of the size of theheart can be compensated, and the correct fit of the sleeve (7) and/orthe sheath essentially remains guaranteed.

In this example, the thicknesses of augmentation units A1 and A2 can beexpanded by about 1.9 cm in order to build up a pressure onto aventricle (here, the left ventricle). The effective volume expansion ofthe augmentation units A1 and A2 in this example is 40 ml. The effectivevolume expansion of the augmentation unit A3 in this example is 50 mland leads to an effective expansion of the thickness by 1.45 cm. Everycorner of an augmentation unit can be described by the coordinates ofthe corner points (vertices). The coordinate system has been explainedin conjunction with FIG. 13.

In this example, augmentation unit A1 extends from vertex 1 (φ=359°;z=100) via vertex 2 (φ=48°; z=85) and vertex 3 (φ=48°; z=40) to vertex 4(φ=328°; z=56), and, in the implanted state, lies flat against the leftventricle. The connection of vertex 1 to vertex 2 essentially extendsparallel to the upper edge of the sleeve (7) at a distance (d) of about5 mm. The connection of vertex 2 to vertex 3 essentially extends alongthe φ=48° line. The connection of vertex 3 to vertex 4 essentiallyextends parallel to the upper edge of the sleeve (7) shown in the3D-model. The connection of vertex 4 to vertex 1 essentially extendsalong the septal line (616). The corners of the augmentation unit A1 arerounded and describe a circular arc with a diameter of 4 mm.

In this example, augmentation unit A2 extends from vertex 1 (φ=116°;z=69) via vertex 2 (φ=182°; z=74) and vertex 3 (φ=212°; z=37) to vertex4 (φ=116°; z=26) and, in the implanted state, lies flat against the leftventricle. The connection of vertex 1 to vertex 2 essentially extendsparallel to the upper edge of the sleeve (7) at a distance (d) of about5 mm. The connection of vertex 2 to vertex 3 essentially extends alongthe septal line (616). The connection of vertex 3 to vertex 4essentially extends parallel to the upper edge of the sleeve (7) shownin the 3D-model.

The connection of vertex 4 to vertex 1 essentially extends along theφ=116° line. The corners of the augmentation unit A2 are rounded anddescribe a circular arc with a diameter of 4 mm.

In this example, the augmentation unit A3 extends from vertex 1 (φ=235°;z=92) via vertex 2 (φ=303°; z=108) and vertex 3 (φ=303°; z=64) to vertex4 (φ=235°; z=48) and, in the implanted state, lies flat against theright ventricle. The connection of vertex 1 to vertex 2 essentiallyextends parallel to the upper edge of the sleeve (7) at a distance (d)of about 5 mm. The connection of vertex 2 to vertex 3 essentiallyextends along the φ=303° line. The connection of vertex 3 to vertex 4essentially extends parallel to the upper edge of the sleeve (7) shownin the 3D-model. The connection of vertex 4 to vertex 1 essentiallyextends along the φ=235° line. The corners of augmentation unit A3 arerounded and describe a circular arc with a diameter of 4 mm.

The positioning unit P in the example of FIG. 17 is designed toessentially fill the spaces between the augmentation units (71) on thesleeve (7). The positioning unit (72) can also be described as apositioning unit (72) with extensions, which fill in the areas of thesleeve (7) that are not filled by the augmentation units. In thisembodiment, the positioning unit P is essentially located at a lateraldistance (d) from the augmentation units (71) and the upper edge of thesleeve (7) of about 5 mm. The positioning unit (72) is also located at adistance from the cutting line (615), which can be advantageous duringmanufacturing. If the sleeve (7) with the expandable unit is formed in atwo-dimensional state, all augmentation units (71) and positioning units(72) can be attached to the sleeve (7) before the sleeve (7) is rolledinto a three-dimensional form.

In the example of FIG. 17, the lines (41) supplying the expandable units(71, 72) are hydraulic or pneumatic lines (41) extending radially fromthe lower edge of the sheath to the augmentation units. The line (41)for the augmentation unit A2 extends along the line φ=15° and ends atthe height of z=54. The line (41) for augmentation unit A2 extends alongthe line φ=165° and ends at the height of z=31. The line (41) foraugmentation unit A3 extends along the line φ=270° and ends at theheight of z=65. The line (41) for the positioning unit P extends alongthe line φ=330° and ends at a height of z=25.

Example #2

FIG. 18 shows an embodiment for a sleeve (80) with at least one sensor(81) and/or an electrode (82). Shown in FIG. 18 is a rollout asdescribed in conjunction with FIG. 13. The sleeve (80) of thisembodiment includes eight sensors (81) or electrodes (82), whereby fourof these are pressure sensors (force sensor FS1, FS2, FS3, FS4) (81),and four are electrocardiogram electrodes (e.g., ECG1, ECG2, ECG3, ECG4)(82). The sleeve (80) can be made of a synthetic material, polymer,natural rubber, rubber, latex, silicon or polyurethane. The sleeve (80)can have a thickness of 0.1 to 1 mm, preferably 0.2 mm to 0.5 mm. Thefour pressure sensors (81) can be integrated into the sleeve (80), forexample, molded or welded to the inside surface of the sheath. Thepressure sensors (81) can be equipped with reinforcements, which canprevent bending during the compression of the device. The ECG electrodes(82) can be attached at the side of sleeve (80) facing the heart. In theembodiment in FIG. 18, a system of coordinates is depicted as describedin conjunction with FIG. 13. Using the coordinate system, the positionsof the sensors (81) and electrodes (82) can be determined as follows:pressure sensor FS1 is located at coordinate (φ=17°; z=71), pressuresensor FS2 is located at coordinate (φ=158°; z=48), pressure sensor FS3is located at coordinate (φ=268°; z=78), pressure sensor FS4 is locatedat coordinate (φ=67°; z=61). ECG electrode ECG1 is located at coordinate(φ=76°; z=54), ECG electrode ECG2 is located at coordinate (φ=352°;z=39), ECG electrode ECG3 is located at coordinate (φ=312°; z=93) andECG electrode ECG4 is located at coordinate (φ=187°; z=18). For smalleror larger hearts, the angular coordinates for the sensors (81) and/orelectrodes (82) essentially remain the same; while the z-value is scaledby a factor. For example, for smaller hearts, the scaling factor can bebetween 0.85 and 0.95, and for larger hearts, the scaling factor can bebetween 1.05 and 1.15.

What is claimed is:
 1. A method of implanting a cardiac device, the method comprising inserting an inner seal member through an opening in a pericardium about a living human heart, the inner seal member having a first sealing lip disposed inside the pericardium and surrounding an aperture through the inner seal member; aligning an outer seal member with the inner seal member, the outer seal member having a second sealing lip disposed outside the pericardium and surrounding an aperture through the outer seal member; securing the inner seal member to the outer seal member, with the first sealing lip engaged against an inner surface of the pericardium and the second sealing lip engaged against an outer surface of the pericardium; and inserting a cardiac device into the pericardium through the apertures of the inner and outer seal members.
 2. The method of claim 1, wherein securing the inner seal member to the outer seal member comprises causing a relative rotation between the inner seal member and the outer seal member to engage a threaded connection between the inner seal member and the outer seal member.
 3. The method of claim 1, wherein the inner seal member is inserted in a collapsed condition, and expands within the pericardium to expose the first sealing lip.
 4. The method of claim 1, wherein inserting the inner seal member comprises first inserting a catheter through the pericardium opening, and then moving the inner seal member along the catheter.
 5. The method of claim 4, further comprising moving the outer seal member into position along the catheter.
 6. The method of claim 1, wherein each of the first and second sealing lips comprise a material selected from the group consisting of polyamide, polyurethane, polyetheretherketone, polyethylene, polypropylene, polycarbonate, polyethylene terephthalate and elastomers.
 7. The method of claim 1, wherein at least one of the first and second sealing lips is of a flexibility that increases with distance from a center of the aperture of the corresponding seal member.
 8. The method of claim 1, wherein at least one of the first and second sealing lips is reinforced with structural reinforcements.
 9. The method of claim 1, wherein at least one of the first and second sealing lips has surface gripping features, the method including engaging tissue of the pericardium with the surface gripping features.
 10. The method of claim 1, further comprising sealing the inserted cardiac device within at least one of the aperture through the outer seal member and the aperture through the inner seal member.
 11. The method of claim 1, wherein the cardiac device further comprises a cable extending through the inner and outer seal members following implantation of the cardiac device.
 12. The method of claim 1, wherein the cardiac device comprises a heart support sheath.
 13. The method of claim 1, wherein the cardiac device comprises a sensor responsive to the heart. 